A nicotine inhaler which closely resembles a cigarette is the first product of its kind to be licensed as a medicine in the UK.
The product, called Voke, which is not electronic, could be provided on prescription to help people stop smoking.
It is also the first device made by a tobacco company to be licensed.
Action on Smoking and Health (ASH) says this could pave the way for electronic cigarettes to be licensed too.
A number of nicotine inhalers, sprays, patches and gums are already available on prescription as aids for stopping smoking, but this is the first device designed to imitate a cigarette which has been licensed by the Medicines and Healthcare products Regulatory Authority (MHRA).
While e-cigarettes are becoming increasingly popular with smokers who want to cut down or stop smoking, as yet none of them is licensed as a medicine in the UK.
No-one yet knows how safe they are, although there is consensus among medical experts that e-cigarettes are less harmful than smoking tobacco.
No batteryThe new nicotine product does not produce ash or smoke and does not involve heat or combustion.
It does not require a battery and only needs the user to inhale.
The licence means the product can only be promoted to smokers and cannot be sold to children.
Deborah Arnott, chief executive of health charity Ash, said she welcomed the decision by the MHRA.
"This new alternative to smoking will allow smokers to choose a product which meets the high standards of medicines regulation and could be provided on prescription to help them stop smoking."
A spokesman from the MHRA said it encouraged companies to submit medicines licence applications for electronic cigarettes and other nicotine-containing products.
Voke is manufactured by Nicoventures, a subsidiary of British American Tobacco. It is not yet available but could be on sale in a few months' time.
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